Medicare Coverage for Device Trials
Prior to enrolling ANY MEDICARE PATIENTS in an IDE or a Post-Market PTA with Carotid Stent Study, you must receive written approval for both Medicare Part A and Part B coverage (Facility and Provider).
Use of an HDE device no longer requires a formal application to Medicare. However, Medicare still has special HDE requirements that need to be completed prior to enrolling any Medicare patients. Contact the CRCE office to discuss these requirements.
Compliance Risk for Improper Billing:
If required processes are not followed and/or approvals are not obtained in advance of submitting a claim to Noridian, Medicare's local contractor, the risks to both hospital and physician claims include:
- No payment for services rendered
- Payment denial
- Denial may include up to the full hospital stay and pro-fees
- Improper payment with subsequent repayment
- Possible false claims risk
Required Informed Consent Language for Noridian IDE Submissions:
Noridian requires that the Informed Consent contain the suggested language in the approved document.
“The <Facility Name> and <PI Name>, the study doctor for this trial, receives funds from the Sponsor – <Sponsor Name> - to cover the costs related to this research. This payment is compensation for the time and resources required for study administration and performance. The study doctors are not receiving additional funding from <Sponsor Name> for participating in this study. They have no financial interest in <Sponsor Name>, including stocks or stock options. Additionally, they do not receive money for activities such as speaking or consultations, honoraria, grants to fund ongoing research or compensation in the forms of equipment or supplies."
Note: The suggested location of the above language may be entered in the “Background” section of the Informed Consent. If the above statement is not accurate and the PI is receiving additional funds, please contact Kristin Kolsch (Kristin.firstname.lastname@example.org) to formulate a new financial statement.
Medicare may provide reimbursement for some investigational devices and related services. Services may be furnished in preparation for device use, contemporaneously with, and necessary to the use of the device, and as follow-up care after device use. Coverage is contingent on the Medicare contractor's approval of the application for reimbursement. Our local Medicare Contractor is Noridian. For additional information please visit the following websites:
- Noridian Part A: Investigational Device Exemption (IDE) Information
- Noridian Part B: Investigational Device Exemption (IDE) Information
- Noridian Part A: Post-Market PTA with Carotid Stent Study Information
- Noridian Part A: Humanitarian Device Exemption (HDE) Information
- View Medicare and FDA References
Next to IDE Coverage Application Steps
Next to HDE Coverage Inforamtion
If you have questions contact: Kristin Kolsch, FDA Compliance Officer at (801)587-0835.